Articles by n8n Publisher

Medtronic Bravo CF Capsule Recall: Critical Lessons for Medical Device Manufacturers on Component Failures

Medtronic Bravo CF Capsule Recall: Critical Lessons for Medical Device Manufacturers on Component Failures

By n8n Publisher |

Medtronic's Bravo CF Capsule recall offers critical lessons for manufacturers on component failures, post-market surveillance,…

Calyxo CVAC Aspiration System Correction: Key Lessons for Medical Device IFU Management

Calyxo CVAC Aspiration System Correction: Key Lessons for Medical Device IFU Management

By n8n Publisher |

FDA announces Calyxo CVAC Aspiration System correction under new Communications Pilot program, highlighting key IFU…

Conavi Novasight Hybrid Catheter Recall: Critical Lessons for Intravascular Device Manufacturers

Conavi Novasight Hybrid Catheter Recall: Critical Lessons for Intravascular Device Manufacturers

By n8n Publisher |

Conavi's Novasight Hybrid Catheter recall highlights critical post-market surveillance gaps. Learn compliance actions for intravascular…

Baxter Sigma Spectrum Infusion Pump Software Recall: Critical Lessons for Medical Device Manufacturers

Baxter Sigma Spectrum Infusion Pump Software Recall: Critical Lessons for Medical Device Manufacturers

By n8n Publisher |

Baxter's Sigma Spectrum infusion pump software recall highlights critical compliance lessons for medical device manufacturers…

FDA Announces Bard PowerPICC Catheter Recall: Critical Safety Alert for Medical Device Manufacturers

FDA Announces Bard PowerPICC Catheter Recall: Critical Safety Alert for Medical Device Manufacturers

By n8n Publisher |

FDA recalls Bard PowerPICC intravascular catheters as part of enhanced communication pilot. Critical compliance insights…

H.R. 6594: New Medical Device Recall Improvement Act Could Transform FDA Notification Requirements

H.R. 6594: New Medical Device Recall Improvement Act Could Transform FDA Notification Requirements

By n8n Publisher |

Rep. Schakowsky's H.R. 6594 proposes electronic recall notifications for medical devices. Learn what this means…

Critical Medical Device Recalls of 2025: Compliance Lessons and Litigation Risks for Manufacturers

Critical Medical Device Recalls of 2025: Compliance Lessons and Litigation Risks for Manufacturers

By n8n Publisher |

Major 2024-2025 medical device recalls are driving litigation and regulatory investigations through 2026, revealing critical…

B. Braun Microbore Extension Set Recall: Key Compliance Lessons for Medical Device Manufacturers

B. Braun Microbore Extension Set Recall: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

B. Braun's microbore extension set recall offers critical compliance lessons for medical device manufacturers navigating…

Abiomed Impella Controller Correction: Critical Lessons in Post-Market Instructions Updates

Abiomed Impella Controller Correction: Critical Lessons in Post-Market Instructions Updates

By n8n Publisher |

Abiomed's Impella Controller correction highlights critical compliance lessons for medical device manufacturers in post-market instruction…

Baxter Novum IQ Infusion Pump Correction: Key Compliance Lessons for Medical Device Manufacturers

Baxter Novum IQ Infusion Pump Correction: Key Compliance Lessons for Medical Device Manufacturers

By n8n Publisher |

Baxter's Novum IQ infusion pump correction offers key compliance insights for medical device manufacturers navigating…

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